FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
77771-183
11-digit product format
777710183
Labeler code
77771
Product ID
77771-183_bd5f421e-db2b-6f83-e053-2a95a90ab05e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Radha Pharmaceuticals, Inc.
Application
ANDA205236
Marketing category
ANDA
Marketing start
2021-03-04
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydralazine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905199, 905222, 905225, 905395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77771-183-01Hydralazine Hydrochloride100 in 1 BOTTLETABLET1001
77771-183-10Hydralazine Hydrochloride1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-183-01EA - Each77771-1831aea8d6d-9a4f-4bff-a884-6c5460e42d7912021-04-08
77771-183-10EA - Each77771-183527b8b76-3512-45bd-a8bb-8f9c4c82e76d12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-183HYDRALAZINE HYDROCHLORIDE TABLET [RADHA PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20210313_149fa857-30ad-451d-b6e2-0000483ccc97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905222hydrALAZINE HCl 100 MG Oral TabletPSNc2638ae6-a210-490f-8389-bbed6a3229c52
905225hydrALAZINE HCl 25 MG Oral TabletPSNc2638ae6-a210-490f-8389-bbed6a3229c52
905395hydrALAZINE HCl 50 MG Oral TabletPSNc2638ae6-a210-490f-8389-bbed6a3229c52
905222hydralazine hydrochloride 100 MG Oral TabletSCDc2638ae6-a210-490f-8389-bbed6a3229c52
905225hydralazine hydrochloride 25 MG Oral TabletSCDc2638ae6-a210-490f-8389-bbed6a3229c52
905395hydralazine hydrochloride 50 MG Oral TabletSCDc2638ae6-a210-490f-8389-bbed6a3229c52
905199hydrALAZINE HCl 10 MG Oral TabletPSN149fa857-30ad-451d-b6e2-0000483ccc971
905222hydrALAZINE HCl 100 MG Oral TabletPSN149fa857-30ad-451d-b6e2-0000483ccc971
905225hydrALAZINE HCl 25 MG Oral TabletPSN149fa857-30ad-451d-b6e2-0000483ccc971
905395hydrALAZINE HCl 50 MG Oral TabletPSN149fa857-30ad-451d-b6e2-0000483ccc971
905199hydralazine hydrochloride 10 MG Oral TabletSCD149fa857-30ad-451d-b6e2-0000483ccc971
905222hydralazine hydrochloride 100 MG Oral TabletSCD149fa857-30ad-451d-b6e2-0000483ccc971
905225hydralazine hydrochloride 25 MG Oral TabletSCD149fa857-30ad-451d-b6e2-0000483ccc971
905395hydralazine hydrochloride 50 MG Oral TabletSCD149fa857-30ad-451d-b6e2-0000483ccc971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77771-183-0177771018301100 TABLET in 1 BOTTLE (77771-183-01) 100 tablet2021-03-040000-00-00NoNoCurrent
77771-183-10777710183101000 TABLET in 1 BOTTLE (77771-183-10) 1000 tablet2021-03-040000-00-00NoNoCurrent